Evidence map›Paper›PMID 34280455›Full record

Trial reportBrazilian journal of anesthesiology (Elsevier)

Palonosetron versus ondansetron for prophylaxis of postoperative nausea and vomiting in laparoscopic cholecystectomy: a non-inferiority randomized controlled trial.

Francisco Jos Chiaradia Davolos, Norma S Modolo, Leandro G Braz, Paulo do Nascimento Junior

Open access · diamondAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Brazilian journal of anesthesiology (Elsevier). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Francisco Jos Chiaradia DavolosUniversidade Estadual Paulista (UNESP), Departamento Especialidades Cir..rgicas e Anestesiologia, Botucatu, SP, Brazil. Electronic address: fdavolos@gmail.com.
Norma S ModoloUniversidade Estadual Paulista (UNESP), Departamento Especialidades Cir..rgicas e Anestesiologia, Botucatu, SP, Brazil.
Leandro G BrazUniversidade Estadual Paulista (UNESP), Departamento Especialidades Cir..rgicas e Anestesiologia, Botucatu, SP, Brazil.
Paulo do Nascimento JuniorUniversidade Estadual Paulista (UNESP), Departamento Especialidades Cir..rgicas e Anestesiologia, Botucatu, SP, Brazil.
Universidade Estadual Paulista (Unesp) · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe tested the hypothesis that, within the margin of 15% of risk difference, palonosetron is not inferior to ondansetron in reducing the incidence of postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy.

methodsWe conducted a double-blind, non-inferiority, randomized, controlled trial of 212 patients aged 18 to 65 years undergoing laparoscopic cholecystectomy under general anesthesia in two secondary care hospitals. Patients were randomly assigned to receive either palonosetron (0.075.ßmg) or ondansetron (8.ßmg) intravenously at induction of anesthesia. Ondansetron (8.ßmg) was also administered 8 and 16.ßhours postoperatively. All anesthetic and surgical procedures were standardized. Patients were evaluated for 24.ßhours postoperatively for the occurrence of PONV.

resultsA high incidence of PONV was observed at 2...6.ßhours postoperatively, with a rate of 36.8% (95% confidence interval [CI] 28.2...46.3) in the palonosetron group, as compared to 43.4% (95% CI 34.4...52.9) in the ondansetron group. The risk difference (95% CI) between palonosetron and ondansetron for PONV was 0 (-10.9 to 10.9) at 0...2.ßhours, -6.6 (-19.4 to 6.5) at 2...6.ßhours, -0.9 (-11.0 to 9.2) at 6...12.ßhours, and -2.8 (-9.6 to 3.6) at 12...24.ßhours. There was no statistically significant difference between the palonosetron and ondansetron groups in the use of rescue medication (dimenhydrinate). There were no adverse events associated with the medications under study.

conclusionPalonosetron is not inferior to ondansetron in patients at risk of PONV undergoing laparoscopic cholecystectomy, providing a good option for PONV prophylaxis, as it can be administered in a single dose.

Indexed as

AntiemeticsCholecystectomy, LaparoscopicAnesthesia, GeneralDouble-Blind MethodHumansOndansetronPalonosetronPostoperative Nausea and VomitingTreatment OutcomeAntiemeticsOndansetronPalonosetronAntiemeticsPostoperative nausea and vomitingPre-exposure prophylaxisRisk factorsTherapeutics

Identifiers

PMID34280455
PMCPMC10877366
OpenAlexW3158201970

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.